FDA.reportPublic FDA data

Natus Medical Incorporated

Matched from indexed company URL: NATUS MEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20239882023988Natus Medical Incorporated1N2026-01-016225 Nancy Ridge Dr SAN DIEGO CA US 92121
96121973002807554Natus Medical Denmark ApS1N2026-01-01Hoerskaetten 9 TAASTRUP Hovedstaden DK DK-2630
30188593018859NATUS MEDICAL INCORPORATED1Y2020-04-255900 FIRST AVE., SOUTH SEATTLE WA US 98108
96121973002807554Natus Medical Denmark ApS1N2020-04-25Hoerskaetten 9 TAASTRUP Region Hovedstaden DK DK-2630
30132428893013242889Natus Medical Incorporated1N2020-04-251183 Quarry Lane, Suite A Pleasanton CA US 94566

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
132541446370493P040025OLYMPIC COOL-CAPMXM2006-12-20
2122401611264281K971799PRECISION FLOW OSV IIJXG1998-02-06
132541181605975K971117WARMETTELHC1997-08-22
2122401857378106K964923CODMAN LUMBAR DRAINAGE CATHETER KITJXG1997-06-25
2122401770324098K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)GWM1996-12-20
2122401016658295K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)JXG1996-10-25
2122401837910908K955832CORDIS VENTRICULAR ANTECHAMBER (VA)JXG1996-03-25
2122401274145477K954021EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)JXG1995-10-24
132541682817518K952649WARM-SCALEFRW1995-08-15
2122401229967970K950315CORDIS CSF RESERVOIRLKG1995-05-09
132541815545842K946229BALANCE MANAGERKHX1995-08-04
2122401096860316K944595CORDIS HORIZONTAL-VERICAL VALVE SYSTEMJXG1995-10-19
132541579548870K935160MINIMUFFSEWE1995-02-09
132541427871541K932881OLYMPIC WARM-LAMPILY1994-01-26
2122401190308639K932273CORDIS TUNNELERGYK1993-08-23
2122402026442823K925810CORDIS POLYPROPYLENE BURR HOLE RESERVOIRJXG1994-03-02
2122401616666668K921936CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTORJXG1992-10-30
2122401310138223K914735VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HMGWM1992-01-17
132541834097024K911955OLYMPIC WARMETTELDQ1991-07-19
2122401299447256K911433RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGEJXG1991-09-16
2122401029984437K910938CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)JXG1991-08-16
161202022107491K910247ZODIAC 901 MIDDLE-EAR ANALYZERETY1991-06-19
2122401039652435K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEGYK1989-10-31
2122401754520275K861377STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVESJXG1986-06-19
2122401413948315K811288SPETZLER LUMBAR-PERITONEAL SYSTEMJXG1981-06-26
2122401601327080K802586AMERICAN HEYER-SCHULTE LOW PROFILE VALVEJXG1980-12-18
2122401937071511K771529PERITONEAL INTRODUCER & SHEATHGYK1977-08-16
3390081750919494K242198ICS Dizcovery (1091)GWN2025-02-14
3390081059094408K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ2024-03-08
3390081509260693K203500RetCam EnvisionHKI2021-04-13
2106591799332854K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableHKI2018-09-07
132541095558818K182178neoBLUE blanket LED Phototherapy SystemLBI2018-12-13
3390081708243813K182178neoBLUE blanket LED Phototherapy SystemLBI2018-12-13
2122401809559173K162437Codman EDS3 CSF External Drainage SystemJXG2016-10-28
2122401447822492K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
161201124322176K161707Madsen ZodiacETY2016-09-01
3390081487501581K161707Madsen ZodiacETY2016-09-01
132541359388888K160745neoBLUE compact LED Phototherapy SystemLBI2016-12-12
3390081921649998K160745neoBLUE compact LED Phototherapy SystemLBI2016-12-12
3390081251971318K160305neoBLUE® LED Phototherapy SystemLBI2016-05-27
132542014137325K160305neoBLUE® LED Phototherapy SystemLBI2016-05-27
2122401062647528K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingJXG2016-03-14
2122401233753583K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryJXG2016-03-04
2122401118846402K152481DURAFORM Dural Graft ImplantGXQ2015-10-30
132541204011015K152301Background Pattern Classification [BPc(TM)]OMA2016-06-03
3390081607419408K151504ICS ImpulseGWN2015-11-16
3390081790566845K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,GWJ2014-08-22
132541982967445K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,GWJ2014-08-22
2122401362815679K133754INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTERGWM2014-03-06
3390081449752607K132957MADSEN ACCUSCREEN TYPE 1077GWJ2014-02-27
161202048193824K132957MADSEN ACCUSCREEN TYPE 1077GWJ2014-02-27
132541489322299K123079OLYMPIC BRAINZ MONITOROMA2013-05-08
161201587731646K122550ICS IMPULSEGWN2013-02-01
3390081708415446K122550ICS IMPULSEGWN2013-02-01
132542071325430K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMEWO2012-11-01
3390081106816766K122067TYPE 1077 ACCUSCREENGWJ2012-09-27
161201200497123K122067TYPE 1077 ACCUSCREENGWJ2012-09-27
161201178071435K122028AURICAL HITETW2012-10-23
3390081494341921K122028AURICAL HITETW2012-10-23
2122401931539437K121573INTEGRA CAMINO ICP MONITORGWM2012-09-10
132541719254077K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMEWO2012-07-26
2122401469956739K121159INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTERGWM2012-07-20
132541000163453K112247A BAER WITH ABAER I/O FUNCTIONEWO2012-04-02
132541004998033K111618AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTIONEWO2011-12-28
3390081129943728K110286GN OTOMETRICS TYPE 1053 FREEFITETW2011-04-28
161201500337505K110286GN OTOMETRICS TYPE 1053 FREEFITETW2011-04-28
132541450224289K103589NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEMLBI2011-05-13
2122401991843813K102875CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; CGWM2010-12-20
2106591134738104K102859RETCAM 3 OPTHALMIC IMAGING SYSTEMHKI2011-04-20
2122401691581351K101381HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMSJXG2011-07-07
132541860638933K093949OLYMPIC BRAINZ MONITOR MODEL OBM70001OMA2010-06-16
2106591158771191K090326RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMSHKI2009-11-25
161201263221500K083399ICS CHARTR EP 200GWJ2009-02-20
132541146649019K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)GWF2009-12-08
161201643222872K081234GN OTOMETRICS INSERT EARPHONESEWO2008-07-14
3390081965088206K081234GN OTOMETRICS INSERT EARPHONESEWO2008-07-14
3390081336256371K073665ALGO 5 NEWBORN HEARING SCREENERGWJ2008-01-25
132541431791737K073665ALGO 5 NEWBORN HEARING SCREENERGWJ2008-01-25
132541941263045K073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMGWJ2008-02-05
161201838621029K061791FOCUS VNG/ENG TYPE 1068GWN2006-07-11
2122401216605962K061568CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738JXG2006-09-29
161201939907511K061443SMART USBLITE, MODEL M011120GWJ2006-06-23
132541031918136K051869NEOBLUE COZY LED PHOTOTHERAPY SYSTEMLBI2005-10-07
2122401817538642K033698CONTOUR-FLEX VALVE AND SHUNT SYSTEMJXG2003-12-17
161201186499806K033645OTOFLEX 100 TYE 1012ETY2004-03-31
3390081522937231K033645OTOFLEX 100 TYE 1012ETY2004-03-31
132541617468374K031352BIO-LOGIC INSERT EARPHONESEWO2003-07-16
132541021162120K031149OLYMPIC CFM 6000OMA2003-05-14
132541311144912K031009MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEMGWJ2003-04-28
132541860470555K030823ALGO 3I NEWBORN HEARING SCREENERGWJ2003-04-09
3390081945818759K030823ALGO 3I NEWBORN HEARING SCREENERGWJ2003-04-09
2122401234615450K022712HAND DRILL, MODEL 11-9901-7HBG2002-11-12
132541768997000K022196NATUS BLUE LIGHT PHOTOTHERAPY UNITLBI2002-09-19
132541463397761K013977ECHO-SCREEN T, TA, TD, TDA, TCGWJ2002-06-14
132541702071051K012384EAR MUFFINSHCC2001-10-15
161201354773372K002200CAPELLAEWO2000-08-25
2106591863337869K001275RETCAM IIHKI2000-07-13
132541127589257
161201268360409
132541300336019
161201631352857
132541693799991
132541767668219
161201783479027
132541810265326
161201831970984
132541939746991
132541956853969
161201981314850
132542042121092
2122401192998598
3390081357683372
3390081556901348
3390081604809084
3390081677190307
3390081770349489
2122401774890116
3390081839351146

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG202016-10-28
GWJ162024-03-08
LBI92018-12-13
EWO82012-11-01
GWM62014-03-06
GWN52025-02-14
HKI52021-04-13
ETY52016-09-01
OMA42016-06-03
ETW42012-10-23
GYK31993-08-23
GXQ12015-10-30
GWF12009-12-08
MXM 12006-12-20
HBG12002-11-12
HCC12001-10-15
LHC11997-08-22
FRW11995-08-15
KHX11995-08-04
LKG11995-05-09
EWE11995-02-09
ILY11994-01-26
LDQ11991-07-19

PMA#

PMN#

RetCam Envision

2021-04-13

Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek)

Natus NeuroWorks

2020-05-18

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Natus NeuroWorks

2018-03-14

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Grass TWin

2018-03-09

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Natus Quantum

2018-02-22

Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK)

Comet-PLUS

2017-11-03

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Trex_HD

2016-11-04

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

GUDID#

83 records. Showing 1-40. Next